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  • 1.  IND Protocol Change - Submission type

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jun-2021 13:23
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    I was looking to get a bit more clarification regarding a scenario. If you increase the number of subjects in a Phase II study, does this need to be submitted as a protocol amendment or can it be captured in the annual IND report?

    Thanks for your help!


  • 2.  RE: IND Protocol Change - Submission type

    Posted 24-Jun-2021 18:26
    Hi anonymous,

    This particular scenario seems to fall squarely within the FDA's description of changes requiring a protocol amendment (from their website on this topic):

    "...changes requiring an amendment to an IND application may include:

    • Any increase in drug dosage or duration of exposure of individual subjects to the drug beyond that described in the current protocol, or any significant increase in the number of subjects under study."

    While it may be tempting to dispute the threshold for what size of increase constitutes a 'significant increase', it is generally safer to submit an amendment rather than capture this an annual report. That being said, if there is a clear provision in the original protocol for increasing the sample size (for instance, an interim analysis or dropout/replacement strategy), this may not require an amendment.

    Cheers,
    Marshall Hoke

    ------------------------------
    Marshall Hoke
    Director of Regulatory Affairs
    Lafayette CO
    United States
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  • 3.  RE: IND Protocol Change - Submission type

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jun-2021 08:07
    This message was posted by a user wishing to remain anonymous

    IND annual report is not meant for reporting changes to protocol!!!! Thus the reason for protocol amendment provision exists which is submitted as an Information amendment to the IND. Please don't confuse this with the NDA/BLA annual reports!! Totally different!